PHARMADRUG
FILES FOR FDA
ORPHAN DRUG DESIGNATION FOR DMT IN KIDNEY TRANSPLANTATION AND
EXPANDS ON ITS PSYCHEDELICS STRATEGY
Toronto,
Ontario--(Newsfile Corp. - February 25,
2021) -
PharmaDrug Inc. (CSE: BUZZ) (OTC: LMLLF) ("PharmaDrug"
or the "Company"),
a specialty pharmaceutical company focused on the research,
development and commercialization of controlled-substances and
natural medicines such as psychedelics,
cannabis
and
naturally-derived approved drugs, is
pleased to announce it has expanded its psychedelic pharmaceutical
program with the filing of an application with the U.S. Food and
Drug Administration ("FDA") to receive Orphan Drug Designation
("ODD") for N,N-Dimethyltryptamine ("DMT") in the prevention of
ischemia reperfusion injury in patients undergoing kidney
transplantation.
Pharmaceutical
Psychedelics Strategy
Following the
acquisition of Sairiyo Therapeutics and its biotech R&D core
competencies, PharmaDrug
has
undertaken efforts to expand its research
activities in the pharmaceutical psychedelics
space. The Company's psychedelic pharmaceutical strategy will focus
specifically on DMT. Through engagement with
respected academics and medical/clinical KOLs in the space,
management will initiate pivotal preclinical and clinical
development activities. Taking advantage of existing
expertise and relationships, PharmaDrug will seek to
broaden its
intellectual property portfolio by creating unique
DMT formulations. Further differentiation in the space will
be
derived from the work that PharmaDrug
will initiate around novel uses for DMT; the ultimate goal of which
is to fuse outstanding science and clinical translation.
"We
have been focused on laying the foundation in becoming
an
industry leader
in the research and development of novel uses for DMT in the
treatment of neuropsychiatric, neurological and inflammatory
disorders,"
said
Daniel Cohen, CEO of PharmaDrug. "Although DMT is commonly
associated with offering an intense psychedelic experience, the
therapeutic potential of DMT is fascinating and remains
underexplored.
We aim to unlock the potential of DMT in
treating unmet
medical needs beyond its potential utility in mental health
disorders. Our orphan drug designation
application for DMT in the prevention of kidney injury during
transplant surgery fits with our psychedelic pharmaceutical
strategy of creating a unique portfolio of DMT therapies targeting
rare disorders while also focusing on foundational research with
DMT to explore and evaluate its therapeutic potential both in the
brain and other human organs."
Kidney
Transplants and DMT
The population of
patients needing renal replacement therapy worldwide
is
estimated to be 5 million. There is a significant worldwide
shortage of suitable kidney donors for transplantation. The number
of kidney transplantations performed worldwide in 2018 was 75.664
[1].
In the U.S., the
Human Resources and Services Administration and the Department of
Health and Human Services Organ Procurement and Transplantation
Network estimated that there are approximately 109,000
individuals currently on the national transplant
waiting list and approximately 92,000 of these are waiting for a
kidney transplant. In 2020, the number of patients receiving a
kidney transplant was 22,871 down 2.5% from 2019 when there were
23,401 kidney transplants.
Ischemia/reperfusion
injury (IRI)
is
caused by a sudden temporary impairment of the blood flow to
a
particular
organ. IRI is associated with a robust inflammatory and oxidative
stress response to hypoxia and reperfusion which disturbs the organ
function.
Quickly
restoring blood supply of ischemic kidney remains
the
cornerstone
for
avoiding
or reducing injury from ischemia.
Additional
strategies
used to attenuate the damage induced by reperfusion
include
ischemic
preconditioning, ischemic postconditioning, and machine
perfusion. These
strategies are expensive, sometimes difficult
to
perform in clinical settings,
and provide
only limited benefit. As such, novel approaches that prevent
transplant associated renal IRI are sorely needed.
Research
studies have shown that DMT activates the sigma-1 receptor
("Sig-1R"), an intracellular chaperone fulfilling an interface role
between the endoplasmic reticulum ("ER") and mitochondria in cells.
Sig-IR ensures the correct transmission of ER stress into the
nucleus resulting in the enhanced production of anti-stress and
antioxidant proteins. DMT
has also been shown to have anti-inflammatory properties.
Consistent
with these
functions,
DMT was
found to mitigate
ischemia-reperfusion injury (IRI) caused by hypoxia,
oxidative
stress and inflammation in
preclinical models of renal
transplantation.[2] The anti-inflammatory protective effects of
DMT may
provide a novel, more beneficial strategy to attenuate the damage
induced by ischemia and reperfusion during kidney
transplantation.
The Orphan Drug Act
grants special status to a drug or biological product to treat a
rare disease or condition upon request of a sponsor. This status is
referred to as orphan designation (or sometimes "orphan status").
The FDA grants ODD status to products that treat rare diseases,
providing incentives to sponsors developing drugs or biologics. The
FDA defines rare diseases as those affecting fewer than 200,000
people in the United States at any given time. ODD would qualify
DMT for certain benefits and incentives, including seven years of
marketing exclusivity if regulatory approval is ultimately received
for the designated indication, potential tax credits for certain
clinical drug testing costs, activities, eligibility for orphan
drug grants, and the waiver of the FDA New Drug Application filing
fee of approximately USD $2,400,000.
About
PharmaDrug Inc.
PharmaDrug is a
specialty pharmaceutical company focused on the research,
development and commercialization of controlled-substances and
natural medicines such as psychedelics, cannabis and
naturally-derived approved drugs. The Company owns 80% of
Pharmadrug Production GmbH, a German medical cannabis distributor,
with a Schedule I European Union narcotics license and German
EuGMP certification allowing for the importation and distribution
of medical cannabis to pharmacies in Germany and throughout the EU.
The Company also owns 100% of Super Smart, a Dutch company building
a modern adult use psychedelic retail business with an elevated and
educational focus. PharmaDrug recently acquired Sairiyo
Therapeutics, a biotech company that specializes in researching and
reformulating established natural medicines with a goal of bringing
them through regulatory and research driven clinical
trials.
For further information, please
contact:
Daniel Cohen, Chairman and
CEO
dcohen@pharmadrug.co
(647) 202-1824
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Forward-Looking Information:
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Although such statements are based on management's reasonable
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forward-looking information contained herein, such as, but not
limited to dependence on obtaining regulatory approvals; the
ability to locate additional supply of medical cannabis, owning
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Sources:
-
Global
Observatory on Donation and Transplantation. 2019. Available
online: http://www.transplant-observatory.org (accessed
on 15 January 2020).
-
Peto
K, Nemeth N, Mester A, Magyar Z, Ghanem S, Somogyi V, Tanczos B,
Deak A, Bidiga L, Frecska E,
Nemes B. Hemorheological and metabolic consequences of renal
ischemia reperfusion
and
their modulation by N,N-dimethyl-tryptamine on a rat model.
Clin Hemorheol
Microcirc. 2018;70(1):107-117. doi: 10.3233/CH-170361. PMID:
29660915.